Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health.
Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stock Exchange and its wholly owned subsidiaries Novartis Healthcare Private Limited, Sandoz Private Limited and Chiron Behring Vaccines Private Limited.
Post: Group Head DRA AMAC/LACan
Job Description
The Hyderabad Group Head for DRA AMAC/LACan Business & Operations Excellence (BoE) provides leadership of the Hyderabad based team responsible for delivering optimal Business & Operational DRA support for Asia, Middle East & African Countries (AMAC) and Latin America & Canada (LaCan).
Working in close partnership with the Head of BoE, the Hyderabad BoE Group Head, will be responsible for assigned activities aimed at maximizing operational effectiveness of the DRA AGL organization (across Global/Regional/CPO interfaces) covering the whole portfolio lifecycle for (GenMed & Oncology).
Major Accountabilities
1. Drives operational excellence in all activities relating to maintenance of DRA business for marketed product portfolio in AMAC/LACan, including but not restricted to licence renewals, site transfers, and other critical activities
2. Ensures excellence in planning & productivity for timely delivery of critical regulatory materials including registration samples & certificates for AMAC/LACan and other regions (as per requirements).
3. Provides operational support for DRA AMAC/LACan regulatory compliance activities.
4. Delivers operational support to regulatory activities related to new product planning, for the AMAC/LACan region.
5. Provides a critical resource to assist in operational aspects around special projects relating to DRA AMAC/LACan.
6. Develops optimal forecasting, resource utilization models and reports to allow efficient monitoring and flexible deployment of resources for delivery of all assigned activities.
7. Leads continuous evaluation of critical processes (productivity and customer satisfaction)
8. Provides leadership in establishing an entrepreneurial culture within the Hyderabad DRA AMAC/LACan BoE team underpinned by business focus, rigorous attention to quality, process innovation and regulatory compliance.
9. Develops and mentors the Hyderabad BoE team to realize their full potential in execution of the operations & business deliverables for DRA AMAC/LaCan.
Key Performance Indicators
• Metrics for submissions, approvals, compliance and other regulatory deliverables according to the business objectives relating to maintenance of business & new product introduction.
• Quality and timely completion of regulatory documentation, for assigned products and for other assigned initiatives.
• Productivity of critical processes and efficiency of resource utilization vs agreed key performance indicators
• Quality and effectiveness of relationships with Novartis internal and external partners.
• Successful development & retention of DRA Hyderabad BoE talent.
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Candidate Profile
Education (minimum/desirable): M.Pharma, B.Pharma with MBA, M.Sc with MBA. PhD/ Pharm D or equivalent scientific degree preferred.
Languages: Fluency in English as a business language
Experience/Professional requirement:
1. Strong leadership and proven people management skills including evidence of enabling superior team performance.
2. Evidence of driving productivity and process improvements in a matrix environment
3. 8-10 years Regulatory experience.
4. Advanced regulatory affairs and/or drug development knowledge with proven regulatory operational leadership a distinct advantage.
5. Excellent interpersonal, communication and negotiation skills, with proven ability to influence effectively in a matrix/ multicultural/multidisciplinary environment.
6. Entrepreneurial approach with a strong quality and compliance ethos
Additional Information:
Experience: 2-3 Years
Location: Hyderabad
Education: M.Pharm, B.Pharm with MBA, M.Sc with MBA, PhD/ Pharm.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 126412BR
End Date: 25th June, 2014
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